510(k) K083878 ยท GIR Reagent, Russel Viper Venom
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
| Applicant | R2 Diagnostics, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Jun 25, 2010 |
| Received | Dec 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083878
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.